KR20190054115A - Sterile packaging system for medical devices - Google Patents

Abstract

A package for a medical device includes a folder having a bottom and top panels, the bottom panel including a leading edge, a trailing edge, and at least one medical device fixation element. The top panel has a leading edge and a trailing edge joined with the trailing edge of the bottom panel. The folder has a folded configuration in which the leading edges of the top and bottom panels face in opposite directions and a folded configuration in which the top panel folds over the bottom panel so that the leading edges of the top and bottom panels are oriented in the same direction and aligned with each other. The folder is insertable into a sealable pouch having a seal having a first leg such that the leading edges of the folder are adjacent the first leg of the seal of the pouch.

Description

Sterile packaging system for medical devices

BACKGROUND OF THE INVENTION

Technical field

This patent application relates generally to medical devices used during surgical procedures, and more particularly to sterile packaging systems for medical devices.

During surgical procedures, much attention is paid to prevent contamination of surgical instruments and medical devices used during the surgical procedure. The surgical team typically includes at least one member whose role is to open the package containing surgical instruments and medical devices and to provide them to the disinfected nurse or surgeon in a manner that remains sterile.

In many cases, a sealed pouch, such as a sealed foil laminate pouch, is used to dispense sterile medical devices and products. For some medical devices, for example, medical devices that require a high degree of moisture protection, a laminate pouch with a foil barrier is needed. Many surgical nurses prefer a sealed pouch having a large open flange with a chevron shaped seal line to facilitate aseptic opening and dispensing of the medical device at the sterilization site. All packages are susceptible to dropping or mis-handling, which in some cases leads to package integrity failure. In addition, foil laminate pouches, particularly when used in three-dimensional devices (e.g., devices having a thickness of one inch or more), can be used when the pouch is damaged during processing and handling in certain cases, and then during transport conditions Is more vulnerable to package integrity infiltration (e.g., holes) than a two-dimensional foil laminate pouch when rigid wrinkles subsequently breakable open can occur.

Some medical devices require packaging that provides moisture to prevent accumulation of excess moisture in the sterile package that may degrade the performance and / or effectiveness of the components contained within the medical device or device. Typically, a moisture-absorbing card may be used to support the medical device before the card and the medical device are inserted into the pouch being sealed to provide a sterile environment inside the package.

Figure 1 illustrates a card 20 having medical device securing elements 22A and 22B that are used to secure medical device 24 onto the upper surface of card 20. [ The card 20 has a leading end 26, a trailing end 28, and a generally rectangular shape. The corners of the card 20 at the leading edge 26 and the trailing edge 28 are rounded. The card may be made of a hygroscopic material, such as a paperboard, or of a more rigid and inert polyethylene material.

Card 20 is designed to support and secure medical device 24 having length, width, and thickness. The medical device 24 is not flat and constitutes a three-dimensional (3D) structure that rests on the card 20. The medical device 24 is secured to the card 20 via the medical device securing elements 22A, 22B.

Referring to Figures 1 and 2a, during the packaging procedure, the leading end 26 of the card 20 is inserted into the sealable foil pouch 30. Referring to FIG. 2A, the foil pouch 30 has three sealed sides 32A, 32B, and 32C and an open non-sealed side 32D. The leading end 26 of the card 20 is inserted into the open end 32D of the foil package 30 such that the leading end 26 is adjacent the sealed end 32B and the rear end (28) closest to the open end (32D). A heat seal 34 is then formed adjacent the proximal end of the foil package 30 to completely seal the card 20 and the medical device 24 within the foil pouch 30 .

Referring to FIGS. 2A and 2B, during handling and shipping, a solid wrinkle or rigid pinch may occur in the sealed foil pouch due to the three-dimensional (3D) nature of the medical device located within the foil pouch. The hard corrugations or tight pinch of the foil pouch may be more impacted during delivery of the package and due to mechanical forces such as vibration. 2A and 2B illustrate a foil pouch 30 having a crease 36 or a rigid pinch that can result in the formation of a complete penetration hole 38. When testing and evaluating packaging, it was observed that the rigid wrinkles in the foil pouch could potentially lead to foil integrity failure due to the formation of pin holes 38 or other defects that destroy the sterilization environment and integrity within the package . Integrity infiltration hole 38 may have a diameter of about 25 to 50 micrometers.

It is believed that one cause of the wrinkling of the foil pouch 30 is that the card 20 and the medical device 24 do not completely fill the interior of the foil pouches because the foil pouches are inwardly directed about the sides of the three- .

In view of the aforementioned drawbacks found in conventional packaging systems for medical devices, it would be desirable to provide a pouch that completely fills the interior of the foil pouch, maintains the pouch smoothly, and prevents hard puckering and pinching of the pouch that could lead to failure of the sterile package There is still a need for a packaging system with a medical device card.

In one embodiment, a package for a medical device includes a folder having a bottom panel and an upper panel. In one embodiment, the bottom panel includes a leading edge, a trailing edge, and at least one medical device fixation element. In one embodiment, the leading edge of the bottom panel may be a straight edge or may have a variety of geometric shapes, including a chevron or curved shape. In one embodiment, the top panel includes a leading edge and a trailing edge that defines a folding line extending between the top panel and the bottom panel in conjunction with the trailing edge of the bottom panel. In one embodiment, the leading edge of the bottom panel can have a variety of geometric shapes including straight edges, chevron shaped edges, or curved edges. In one embodiment, the folder includes an unfolded configuration in which the leading edges of the top and bottom panels are directed in opposite directions, and wherein the top panel is folded over the bottom panel at the fold line and the leading edges of the top and bottom panels are oriented in the same direction, Respectively.

In one embodiment, the bottom panel has first and second lateral edges extending from the leading edge of the bottom panel to the trailing edge of the bottom panel. In one embodiment, the bottom panel includes a first stress relieving slit extending inwardly from the first side edge toward the center of the bottom panel, and a second relief slit extending inwardly from the second side edge toward the center of the bottom panel And a second stress relief slit. In one embodiment, the first and second stress relief slits are aligned with each other along the length of the bottom panel.

In one embodiment, the top panel has first and second side edges extending from the leading edge of the top panel to the trailing edge of the top panel. In one embodiment, the top panel includes a first stress relief slit extending inwardly from the first side edge toward the center of the top panel, and a second stress relief slit extending inwardly from the second side edge toward the center of the top panel, Respectively. In one embodiment, the first and second stress relief slits of the top panel are aligned with one another along the length of the top panel.

In one embodiment, when the folder is in the folded configuration, the first stress relief slit of the top panel is aligned with the first stress relief slit of the bottom panel, and the second stress relief slit of the top panel is aligned with the second stress relief slit of the bottom panel Aligned with the slit.

In one embodiment, at least one of the stress relief slits has a hole at its inner end. In one embodiment, at least one of the stress relief slits has an oval or ovoid shape. In one embodiment, the outer ends of the stress relief slits adjacent to the lateral edges of the panels are rounded or curved to optimize pouch smoothness when the folder containing the three-dimensional medical device is inserted into the sealable pouch.

In one embodiment, the medical device is fixed on the bottom panel of the folder, and the top panel covers the medical device when the folder is in the folded configuration. In one embodiment, the medical device is a three-dimensional medical device having a length, width, and thickness that extends over an inner major face of the bottom panel.

In one embodiment, the bottom panel has at least one medical device securing element for securing the medical device to the bottom panel. In one embodiment, the at least one medical device securing element is configured to securely engage the bottom panel through a fold line that allows at least one medical device securing element to be folded flat onto the bottom panel or extended away from the bottom panel to engage the medical device. Lt; / RTI > In one embodiment, the bottom panel has first and second medical device fastening elements.

In one embodiment, the package includes a sealable pouch, wherein the sealable pouch includes a first leg extending adjacent a leading end, and a first side and a second side of the pouch, And second and third legs extending adjacent to the first and second legs. In one embodiment, the first leg of the seal has a chevron shape that coincides with the edges of the top and bottom panels of the folder. In one embodiment, the first leg of the seal has a straight edge that coincides with the straight leading edges of the top and bottom panels of the folder. In other embodiments, the first leg of the seal may have other geometric shapes (e.g., curved) that conform to the geometric shapes of the leading edges of the top and bottom panels of the folder.

In one embodiment, the folder is configured such that the leading edges of the top and bottom panels are adjacent to the first leg of the seal of the pouch and the first side edges of the folder are adjacent to the respective second and third legs of the pouch seal In the pouch.

In one embodiment, the seal includes a fourth leg extending between the second and third legs of the seal and adjacent the rear end of the pouch to seal the folder and the medical device in the pouch. In one embodiment, the trailing end of the sealed pouch comprising the fourth leg of the seal is folded under the folder to form the pouch fold. In one embodiment, the pouch fold is adjacent the trailing edge of the folder disposed within the pouch.

In one embodiment, the package includes a sales unit carton having a leading end and a trailing end, and a plurality of sealed pouches disposed within the unit carton. In one embodiment, each sealed pouch has a folded rear end adjacent the rear edge of the folder to which the folder is folded. In one embodiment, when the sealed and folded pouch is inserted into the sales unit carton, the pouch fold is adjacent the leading edge of the sales unit carton and the first leg of the pouch seal is positioned adjacent the trailing edge of the sales unit carton.

In one embodiment, the folder is made of hydrophilic material, cardboard, cardboard, and / or high density polyethylene (HDPE). In one embodiment, when the folder containing the three-dimensional medical device is inserted into the pouch, the outer surfaces of the upper and lower panels of the folder preferably smooth the upper and lower panels of the pouch, Minimize the possibility.

In one embodiment, the pouch can be made from a variety of materials including, but not limited to, foils, foil polyester laminates, and foil nylon laminates.

In one embodiment, a package for a medical device includes a sealed pouch, wherein the sealed pouch includes a first leg extending adjacent a leading edge of the pouch, a second leg extending adjacent the first and second sides of the pouch, And two material sheets joined together by a seal having third legs and a fourth leg extending adjacent the rear end of the pouch. In one embodiment, the first leg of the seal has a chevron shape, a curved shape, a straight line, or other geometric shape.

In one embodiment, the package includes a folder including a medical device, such as a three-dimensional medical device, having length, width, and thickness. In one embodiment, the folder has a lower panel and an upper panel. In one embodiment, the bottom panel has a leading edge and a trailing edge, the top panel having a leading edge and a trailing edge defining a fold line extending between the top panel and the bottom panel in combination with the trailing edge of the bottom panel . In one embodiment, the top panel is folded over the bottom panel from the fold line, and the leading edges of the top and bottom panels are oriented in the same direction and aligned with one another. In one embodiment, the folder containing the three-dimensional medical device is disposed within the sealed pouch with the leading edges of the top and bottom panels of the folder adjacent the first leg of the sealed pouch seal.

In one embodiment, the bottom panel includes first and second side edges extending from the leading edge of the bottom panel to the trailing edge of the bottom panel, a first stress relief extending from the first side edge inwardly toward the center of the bottom panel, And a second stress relief slit extending inwardly from the second side edge toward the center of the bottom panel. In one embodiment, the first and second stress relief slits are aligned with each other along the length of the bottom panel. In one embodiment, the outer ends of the stress relief slits adjacent to the side edges of the bottom panel are rounded or curved to optimize pouch smoothness when the folder is inserted into the pouch.

In one embodiment, the top panel includes first and second side edges extending from the leading edge of the top panel to the trailing edge of the top panel, a first stress relief extending from the first side edge inward toward the center of the top panel, And a second stress relief slit extending inwardly from the second side edge toward the center of the upper panel, wherein the first and second stress relief slits of the upper panel are aligned with each other along the length of the upper panel. In one embodiment, the outer ends of the stress relief slits adjacent to the side edges of the top panel are rounded or curved to optimize pouch smoothness when the folder is inserted into the pouch. The embodiment also protects the pouch from potential damage from otherwise otherwise pointed loaded, folded geometry.

In one embodiment, when the top panel is folded over the bottom panel, the first stress relief slit of the top panel is aligned with the first stress relief slit of the bottom panel, and the second stress relief slit of the top panel is aligned with the second Aligned with the stress relief slit.

In one embodiment, the package includes a medical device (e.g., a three-dimensional medical device having a length, width, and thickness) secured to a folder, whereby the medical device has a section forming the thickest portion of the medical device, Whereby the stress relief slits on the top and bottom panels are aligned with the thickest portion of the medical device.

In one embodiment, the device packaging assembly includes a generally rectangular pouch that is sealed at at least three sides. A medical device is supported on a profiled folder made of a substantially flat material. In one embodiment, the folder is made of a material that is thermally resistant. In one embodiment, the folder is water absorbent or hydrophobic and sized to fit snugly on the pouch at least on three sides. In one embodiment, the term " snug fit " is defined as a distance of less than 5 millimeters between the outer perimeter of the device-loaded folder and the inner edges of the seal within the pouch.

In one embodiment, after the folder is inserted into the pouch, the fourth side of the pouch is sealed adjacent to or near the rear end of the folder. The sealed fourth side of the pouch is folded to form a pouch fold with a fold line adjacent or immediately adjacent to the trailing edge of the device-loaded folder. The pouch folds can be rounded or pinned.

In one embodiment, the profiled folder is further profiled by having at least one strain relief slit. In one embodiment, the at least one stress relief slit is preferably adjacent to a maximum thickness of the medical device secured on the folder. In one embodiment, the at least one stress relief slit ends at the periphery of the folder starting from the hole near the center of the folder. In one embodiment, the opening has a smaller diameter than the width of the pressure relief slit. In one embodiment, the opposing walls of the slits have an oval or oval shape. In one embodiment, the stress relief slit defines a gap within the folder having a width of about 1 to 5 millimeters. In one embodiment, the outer ends of the stress relief slits at the periphery of the folder have rounded or curved surfaces to optimize pouch smoothness. The embodiment also protects the pouch from potential damage from otherwise otherwise pointed loaded, folded geometry.

In one embodiment, the profiled folder has anti-rotation features including raised sections on the medical device that meet raised sections on the folder.

In one embodiment, a semi-flexible foil laminate packing system utilizes a two-sided sleek folder to hold and secure the medical device within the foil laminate pouch. The semi-flexible foil laminate packaging system preferably includes folding the sealed pouch over a well seated device-loaded folder to secure the packaging system.

In addition to any potential soft spot that may be more susceptible to external damage, a hard fold that can result during the life of the package and smoothing the pouch to minimize wrinkles, a smooth folder within the folded foil laminate pouch Supports the pouch internally to further protect the package from external damage, hard folds and creases.

In one embodiment, the unit carton for the medical device may include a foam insert. In one embodiment, the foam insert preferably comprises a low density polyethylene foam (LDPE) insert (e.g., 1.7 # density). In one embodiment, the foam insert includes a central notch or elongated window formed therein. The central notch can be used to maintain the integrity of the sealed package (e.g., at the apex of the chevron shaped seals at the leading edges of the chevron shaped top and bottom panels of the folder) and the impact of a severe drop impact force on the pouch As a buffer element for minimizing the amount of noise. In addition, the notch in the foam insert also allows visual inspection to ensure that the pouches loaded into the unit carton are loaded in their correct orientation. In one embodiment, the unit-of-sale carton containing the sealed pouch is sized to minimize pouch movement. In one embodiment, the pouch opening flange of the pouch is dried to a small extent smoothly to fit into the unit carton with the protective foam insert. The foam insert for the carton further protects the above-described packaging system from drop impact and drop-related damage.

In one embodiment, to prevent wrinkles (e.g., when the foil collapses inwardly about the sides of the medical device contained within the package), a smooth folder is disposed within the sealed pouch and fills the interior of the pouch .

These and other preferred embodiments of a package for a medical device will be described in more detail below.

1 shows a medical device supported on a card.
Figures 2a and 2b illustrate the pouch housing the medical device and the card shown in Figure 1;
Figures 3a and 3b illustrate a folder for securing a medical device, according to one embodiment of the present invention.
Figure 4 illustrates a sealable pouch housing a folder as shown in Figures 3A and 3B, in accordance with an embodiment of the present invention.
Figures 5A-5G illustrate a method of securing a medical device on a folder and sealing a resulting subassembly within a sealable pouch, according to one embodiment of the present patent application.
Figures 6A-6H illustrate a method of packing the sealed pouch of Figure 5G within a carton, in accordance with an embodiment of the present invention.
Figures 6i and 6j illustrate a method of packing the carton of Figure 6h into a shipping container, according to one embodiment.
7A-7D illustrate a method of sealing and folding a pouch for a medical device, according to one embodiment.
Figures 8A and 8B illustrate a method of packing sealed pouches containing a medical device in a carton having a foam insert, according to one embodiment.
Figures 9a and 9b illustrate a method of packing sealed pouches in a carton containing medical devices, according to one embodiment.
10A illustrates a package for a medical device, including a protective frame surrounding a sealed pouch housing a medical device, according to one embodiment.
Figure 10B illustrates a plurality of packages shown in Figure 10A inserted into a carton, in accordance with an embodiment of the present invention.
11 illustrates a package for a medical device, including a protective frame surrounding a sealed pouch housing a medical device, according to another embodiment.
12 illustrates a plurality of packages shown in FIG. 11 inserted into a unit-of-sale carton having a tear away front, according to one embodiment;
Figures 13A and 13B illustrate a method of packing sealed pouches in a carton containing medical devices, according to one embodiment.
Figure 14 illustrates a carton for sealed pouches that receive a medical device, according to one embodiment, having a foam insert for buffering sealed pouches packed therein.

Referring to FIG. 3A, in one embodiment, a folder 100 for receiving a medical device includes a bottom panel 102 and an upper panel 104 designed to fold over the bottom panel 102. Folder 100 is preferably made of a durable inert material such as high density polyethylene (HDPE). In one embodiment, the bottom and top panels 102, 104 of the folder 100 each have a thickness of approximately 25 mils.

In one embodiment, the bottom panel 102 of the folder 100 includes a leading edge 106, a trailing edge 108, and first and second side edges 108, 108 extending between the leading edge 106 and trailing edge 108. The bottom edge 102, And lateral edges 110,112. In one embodiment, the leading edge 106 of the bottom panel 102 has an angled chevron shape with a vertex coinciding with the angled chevron shape of the seal found at the sealed end of the pouch. In one embodiment, the corners 114A, 114B of the leading edge 106 of the bottom panel 102 are rounded where the leading edge 106 meets the first and second side edges 110, 112.

In one embodiment, the bottom panel 102 includes a first medical device securing element 116 having a base flexibly secured to the bottom panel 102 via a fold line 118, The element 116 may be folded flat against the top surface of the bottom panel 102 or may extend upright away from the top surface of the bottom panel 102 in an upright configuration. In one embodiment, the first medical device fixation component 116 includes an opening (not shown) configured to receive a certain section (e.g., a plunger section) of the medical device to secure the medical device on the bottom panel 102 of the folder 100 120).

In one embodiment, the bottom panel 102 of the folder 100 includes a second medical device securing element 122 having a base that is flexibly secured to the bottom panel 102 via a fold line 124. The second medical device securing element 122 may be folded flat against the upper surface of the bottom panel 102 or may be folded over the bottom panel 102 (e.g., Of the upper surface of the base plate. The second medical device securing element 122 includes an opening 126 configured to receive and seat a portion of the medical device secured on the bottom panel 102 of the folder 100.

The bottom panel 102 of the folder 100 includes a first stress relief slit 128 extending inwardly from the first side edge 110 and a second stress relief slit 128 extending inwardly from the second side edge 112. In one embodiment, And a second stress relieving slit (130). In one embodiment, the first and second stress relief slits 128, 130 are aligned with one another along the longitudinal axis of the bottom panel 102. In one embodiment, the first and second stress relief slits are positioned between the first and second medical device fixation elements 116, 122. In one embodiment, when the three-dimensional medical device is secured over the bottom panel 102, the first and second stress relief slits are aligned with the thickest section of the medical device secured onto the bottom panel 102 of the folder 100 do. In one embodiment, the outer ends of the stress relief slits have a curved or rounded surface 135 adjacent the side edges 110, 112 of the bottom panel 102.

In one embodiment, the opposed laterally extending walls 132, 134 of the first stress relief slit 128 have an oval or elliptical shape and the innermost end of the first stress relief slit 128 has a rounded apex (136). In one embodiment, the rounded apex 136 has a smaller diameter than the width of the first stress relief slit 128. Although the present invention is not limited by any particular theory of operation, it is contemplated that the walls 132, 134 of opposite oval shapes, the rounded apex 136 at the innermost end of the stress relief slit, and the rounded or curved outer end Providing a first stress relief slit 128 having a plurality of pockets 135 to provide better smoother capability for the sealable pouch and to eliminate or minimize the possibility that any sharp edges on the folder 100 will contact the walls of the pouch ≪ / RTI >

In one embodiment, the second stress relief slit 130 has opposing sidewalls 138, 140 having an elliptical or oval shape and a rounded apex 142 at the innermost end of the second stress relief slit . In one embodiment, the rounded apex 142 has a smaller diameter than the width of the second stress relief slit 130.

In one embodiment, the top panel 104 of the folder 100 includes a leading edge 144, a trailing edge 146, and first and second side edges 146 extending between the leading edge 144 and trailing edge 146 (148, 150). In one embodiment, the leading edge 144 is configured to have an angled chevron shape of the leading edge 106 of the bottom panel 102 of the folder 100 as well as an angled chevron shape of the hermetically sealed pouch And has an angled chevron shape having apexes that coincide with the angled chevron shape of the end portion. In one embodiment, the leading edge 144 of the top panel 104 includes rounded corners 152A and 152B extending between the leading edge 144 of the top panel and the first and second side edges 148 and 150, .

The top panel 104 of the folder 100 includes a first stress relief slit 154 extending inwardly from the first side edge 184 and a second stress relief slit 154 extending inwardly from the second side edge 150. In one embodiment, And a second stress relief slit (156). In one embodiment, the first stress relief slit 154 has opposed first and second walls 158, 160 having an oval or elliptical shape. In one embodiment, the rounded apex 162 defines the innermost end of the first stress relief slit 154.

In one embodiment, the second stress relief slit 156 of the bottom panel 104 has opposing sidewalls 164 and 166 having an oval or elliptical shape and a second stress relief slit 156 at the innermost end of the second stress relief slit 156 Rounded vertex 168. In one embodiment, the first and second stress relief slits 154, 156 of the top panel are aligned with one another along the length of the top panel 104 of the folder 100. In one embodiment, the outer ends of the stress relief slits of the top panel have rounded or curved surfaces 163.

The trailing edge 108 of the bottom panel 102 of the folder 100 and the trailing edge 146 of the top panel 104 of the folder 100 allow the top panel 104 to be positioned on the bottom panel 102, Are folded together along a foldable new score line 170 that allows them to fold up. The first stress relieving slit 154 on the top panel 104 is spaced apart from the first stress relieving slit 128 on the bottom panel 102 when the top panel 104 is folded over the bottom panel 102. In one embodiment, And the second stress relief slit 156 on the top panel 104 is aligned with the second stress relief slit 130 on the bottom panel 102. [ In one embodiment, the stress relief slits are aligned with the thickest section of the three-dimensional medical device secured to the bottom panel 102 of the folder 100. In one embodiment, the stress relief slits have an oval or oval shape and terminate at rounded vertices having diameters smaller than the thickness of the slits associated therewith.

3A and 3B, in one embodiment, a medical device is positioned over a bottom panel 102 of a folder 100 and the first and second medical device fixation elements 116, Respectively. The top panel 104 includes a fold line 170 so that the top edge 104 of the top panel 104 is aligned with the top edge 104 of the bottom panel 102. In one embodiment, Lt; RTI ID = 0.0 > 102 < / RTI > In addition, the first stress relief slit 154 of the top panel 104 is aligned with the first stress relief slit 128 of the bottom panel 102, and the second stress relief slit 156 of the top panel 104 Is aligned with the second stress relief slit (130) of the bottom panel (102). The medical device is preferably disposed between opposing inner surfaces of the top and bottom panels.

In one embodiment, the folder is comprised of a high density polyethylene material (HDPE) or similar inert and durable material. The folder can be tailored to each particular medical device and each particular foil laminate pouch. In one embodiment, the folder is preferably made of a hydrophilic material. In one embodiment, the folder is made of a cellulosic material such as paper or paperboard. The folder may act as a desiccant material for removing excess moisture from within the sealed package or from a medical device stored within the sealed package.

Referring to FIG. 4, in one embodiment, the folder 100 shown in FIGS. 3A and 3B and described above is insertable into a sealable pouch 174 having a closed end 176 and an open end 178. In one embodiment, the sealable pouch can be a foil and a foil laminate pouch comprising polyester and / or foil and nylon. The sealable pouch 174 includes a sealant 180 in the form of a sheath that is adjacent to the closed end 176 of the pouch 174 and first and second side edges 182 extending along the side edges of the pouch 174. In one embodiment, Is a foil pouch that is initially sealed along three sides including the seals 182 and 184. In one embodiment, the sheath-shaped seal 180 has a shape and configuration that coincides with the bottom of the folder 100 (FIG. 3A) and the chevron shape of the leading edges 106, 144 of the top panels 102, Respectively. The first and second side seals 182 and 184 extend from the outer ends of the chevron shaped seal 180 toward the open end 178 of the foil patch 174. In one embodiment, the pouch 174 includes two layers of material joined together by the shebra-shaped seal 180 and the first and second side seals 182, 184. In one embodiment, the leading edges of the top and bottom panels and the seal 180 may have various geometric shapes (e.g., curved, straight) that coincide with one another.

In one embodiment, the foil laminate pouch for the medical device is preferably bonded together by one or more seals to define a sealed area of the pouch that is located within the seal and an unsealed area of the pouch that is located outside the seal And first and second flexible sheets having opposed inner surfaces. The pouch preferably has an open flange positioned adjacent the edge of the pouch to dislodge the seal to remove contents within the sealed pouch and to peel away the first and second sheets away from each other to open the sealed pouch . In one embodiment, the open flange is preferably located within the unsealed region of the pouch.

In one embodiment, the folder containing the medical device is preferably disposed within the sealed region of the pouch. The sealed area is preferably sterile to maintain the folder and the medical device in a sterile condition. The folder and the medical device are preferably removable from the pouch by breaking away the seal and stripping the first and second sheets of the pouch apart from each other to open the sealed pouch.

In one embodiment, the pouches may be made from sheets of continuous roll stock. Sheets of continuous roll stock can be conveyed downstream by a conveyor system to a sealing station where the sheets are sealed to define a plurality of distinct pouches. The plurality of pouches may be cut from the roll stock to provide a plurality of distinct pouches. The order of steps for sealing and cutting may be changed as needed. In one embodiment, the rollstock may be sealed first and then cut into separate pouches. In one embodiment, the pouches are first cut into separate pouches, and then sealed. The above steps may be performed by the pouch manufacturer to provide a plurality of sealed pouches, each pouch having a pouch opening configured to receive a folder containing the medical device.

In one embodiment, the seal preferably extends adjacent the first side, second side, and leading edge of the pouch. Initially, the trailing edge of the pouch remains unsealed. The seal may be formed using adhesive, heat, energy or pressure, or a combination thereof. In one embodiment, the seal preferably includes a first leg extending adjacent the leading edge of the pouch, a second leg extending adjacent the first side edge of the pouch, and a second leg extending adjacent the second side edge of the pouch And a third leg. In one embodiment, the first leg at the leading edge has a chevron shape with a vertex that divides the first leg into a first section and a second section. In one embodiment, the first and second sections of the first leg of the seal's chevron shape are preferably angled relative to one another. In one embodiment, the first section of the first leg defines an angle of about 10 to 20 degrees, more preferably about 15 degrees with the leading edge of the pouch. The second section of the first leg defines an angle in a range similar to the leading edge of the pouch. In one embodiment, the seal has a width of about 5 to 10 mm. In one embodiment, the first leg of the seal at the leading edge may have a different geometric shape, including curved and straight edges that conform to the shape of the leading edge of the folder.

3A) is preferably inserted into the opening 178 (i.e., the unsealed end) of the foil patch 174 before the open end 178 of the pouch is sealed, and the folder 100 And the medical device housed on the folder is sealed inside the pouch 174. In one embodiment, the pouch 174 includes a pouch opening flange 174 located outside the sealed region of the pouch, which allows the two bonded layers of material to be pulled apart to break the seal and access the folder within the pouch. (Not shown).

3A and 4, in one embodiment, the lateral distance between the first side and the second side of the bottom panel 102 of the folder and the top panel 104 is denoted by D ₁ , and a substantially matched to the distance D ₂ between the second side seal (182, 184). As a result, once the folder 104 has been inserted into the open end 178 of the pouch, the folder 104 will not move laterally within the pouch 174. In one embodiment, the top ends of the top and bottom panels 102,104 of the folder 100 are adjacent to the inside of the cervical shaped seal 180 at the closed end 176 of the pouch 174 . After the folder 100 is fully inserted into the pouch 174, the open end 178 preferably has a fourth seal (not shown) extending from the first side seal 182 to the second side seal 184, As shown in Fig.

Referring to Figure 5A, in one embodiment, the folder 100 is laid flat so that the bottom panel 102 and the top panel 104 are in a common plane. The medical device 186 is juxtaposed with the upper surface of the bottom panel 102.

Referring to Figures 5A and 5B, in one embodiment, the respective openings 120, 126 of the first and second medical device fastening elements are opposed to the underside of the medical device 186, The stationary elements 116, 122 are standing upright. Referring to Figure 5b, sections of the medical device 186 are secured to the openings 120, 122 of the first and second medical device securing elements 116, 122 to secure the medical device to the bottom panel 102 of the folder 100. [ 126).

Referring to Figures 5b and 5c, in one embodiment, the top or inner surface of the top panel 104 covers the medical device 186 and faces the top or inner surface of the bottom panel 102 The upper panel 104 is folded over the bottom panel 102 of the folder 100. In one embodiment, the top panel 104 and bottom panel 102 are folded along a fold line 170 interconnecting the trailing edge 108 of the bottom panel and the trailing edge 146 of the top panel. 5C, after the top panel 104 is folded over the bottom panel 102, the leading edges 144, 106 of their respective top and bottom panels are aligned with one another. In addition, the first stress relief slit 154 of the top panel 104 is aligned with the first stress relief slit 128 of the bottom panel 102, and the second stress relief slit 156 of the top panel 104 Is aligned with the second stress relief slit (130) of the bottom panel (102).

5D, in one embodiment, a folder having a medical device is designed to be inserted into a pouch 174 having an open end 178 and a closed end 176 into which the leading edges of the folder are inserted. The pouch includes a first end 188 extending from the outer ends of the sheath-shaped seal 180 adjacent the closed end 176 and a second end 188 extending toward the open end 178 of the pouch 174, Side seals 182,184. ≪ / RTI >

Referring to Figure 5E, in one embodiment, with the folder 100 in its folded configuration, the top edges 144 and 106 of the top and bottom panels of the folder, (178). The tip edges 144 and 106 of the chevrons form a chevron shaped seal 180 of the pouch 174 until the chevron shaped leading edges 144 and 106 contact the chevron shaped seal 180. [ Lt; / RTI >

5F, a fourth seal 186 is formed at the open end 178 of the pouch 174 after the folder is fully inserted into the pouch 174. In one embodiment, a fourth seal 186 extends between the first and second side seals 182, 184 to fully seal the folder 100 and the medical device within the pouch 174.

Referring to FIGS. 5F and 5G, in one embodiment, the folder is fully seated within the pouch 174 such that the leading edges of the cuffed, shaped folded folder are adjacent the cefral shaped seal 180 of the pouch. The sealed end 178 of the pouch including the fourth seal 186 is folded about the rear edges of the top and bottom panels of the folder. In one embodiment, the sealed end 178 is folded to rest under the bottom panel of the folder. In one embodiment, care must be taken not to pinch the pouch along the fold line when the sealed fourth end 178 of the pouch 174 is folded over the rear edge of the folder. In one embodiment, the fold line 188 is located proximate or adjacent to the top of the folder received in the sealed pouch 174 and the trailing edges of the bottom panels.

Referring to Figure 6A, in one embodiment, a carton 190, such as a sales unit carton, is used to store a sealed pouch 174 (see Figure 5G). The sales unit carton 190 includes a body 192 having a box-like shape, a front closure flap 194, and a rear closure flap 196. The front closure flap 194 and the leading edge of the body 192 can be removed to provide access to the front of the carton 190 and the sealed pouch loaded within the carton, as described in greater detail herein Removable tear panel (198).

Referring to Figure 6B, in one embodiment, the body 192 is positioned such that the front of the body 192 has a box-like shape that is covered by the front flap 194 and the removable tear panel 198. [ (190) is assembled. The rear flap 196 covering the rear end of the body 192 is opened so that the sealed pouch packages 174 can be inserted into the carton 190. [

In one embodiment, the folded end 178 of each sealed pouch 174 is juxtaposed with the opening from the rear end of the carton 190 to the body 192, as shown in FIG. 6B. The folded end 178 of the sealed pouch is inserted into the rear opening and advanced toward the front panel 194 of the carton 190. [ The cebron shaped seal 180 of the pouch 174 is directed away from the front panel 194 and toward the rear end or rear end of the body 192 after being loaded into the carton.

6C, in one embodiment, a set of sealed pouches 174A through 174E may be inserted into the opening at the rear end of the body 192 of the carton 190. [ Each sealed pouch 174A-174E has a tongue-like pouch 174A-174E with the folded end portions 178 of their pouches first entering and the sealed end portions 180 of the chevron shape facing the rear or rear end side of the body. Are similarly oriented.

6D, in one embodiment, an instruction for use (IFU) manual 200 is placed over the top sealed foil package loaded in the body 192 of the unit carton 190 . Figure 6d shows an embodiment in which five sealed pouches are loaded into the unit-of-sale carton 190, but in other embodiments fewer or more sealed pouches may be loaded into the unit-of-sale carton.

6E, after the sealed pouches are loaded into the carton 190, the rear panel 196 is positioned on the front panel 194 of the body 192 so that the body 192 of the carton 190 Is rotated. In one embodiment, the pouch opening flanges 185 of all the sealed pouches 174 are rounded in the same direction.

6E and 6F, in one embodiment, before the rear flap 196 of the unit-of-sale carton 190 is closed, the foam insert 202 is pushed through a rounded open flange (not shown) of the sealed pouches 174 185). In one embodiment, the foam insert 202 preferably includes a window 204 extending across the height H ₁ of the body 192 of the carton 190. The long inspection window 204 provides various functions. The first function is to provide a check window to ensure that the pouch opening flanges 185 are rolled uniformly in the same direction. The second function is to move the vertex of the shear-like seal 180 (Fig. 4) of the pouch 174 and the apex of the shear-like tip edges 106, 144 of the folder 100 Which provides improved buffering action on the sealed pouches. The rear side of the carton 190 then moves the first and second side flaps 206A and 206B over the foam insert 202 and the rear flap 196 to the first and second side flaps 206A and 206B It can be closed by folding it up.

6G, in one embodiment, a first security label 208 may be placed at the corner edge between the front flap 194 and the front end of the main body 192. As shown in FIG. The second security label 210 can be positioned between the rear flap 196 and the rear end of the body 192. [ The first and second security labels 208 and 210 provide confirmation that the carton 190 has not been tampered with and / or that an unauthorized opening of the carton 190 has been done.

6H, in one embodiment, each packaged unit-of-sale carton 190 includes a plurality of the sealed and folded pouches described herein, preferably stacked on top of each other within the carton 190 do. The folded sealed ends of the pouch are adjacent to the front flap 194 and the sealed ends of the coblened shape of the pouches are adjacent to the rear flap 196 of the carton 190.

Referring to Figures 6h and 6i, in one embodiment, a plurality of fully assembled cartons 190 may be packed in a shipping container 210 that is designed to receive two or more selling unit cartons 190. In one embodiment, before inserting the unit-of-sale cartons 190 into the shipping container 210, the cartons 190 are positioned such that the tear panels 198 on the fronts of their respective bodies 192, Is oriented to be oriented toward the closed bottom end (212).

Referring to Figures 6i and 6j, in one embodiment, after the cartons 190 are loaded into the shipping container 210, the upper closing flaps 214A-214D of the shipping container are folded over the open end of the shipping container, And may be held in a closed configuration by a shipper tape 216 extending across the width and sides of the shipping container 210. The tipper tape 216 may also be used to secure the closure panels at the closed end 212 of the shipping container 210.

7A, in one embodiment, the sealable pouch 174 is configured to receive a sealed end 176 having a pouch open flange 185 and a folder 100 (FIG. 3A) And an open end 178 that is not sealed. The pouch 174 includes a cervical shaped seal 180 at the sealed end 176 and a seal 180 extending from the outer ends of the cervical shaped seal 180 to the open end 178 of the pouch 1 and second side seals 182, 184.

7B, in one embodiment, the leading edges of the folder are inserted into the open end 178 of the pouch 174, and the leading edges of the cobra shaped features of the folder are positioned inside the cebra shaped seal 180 And is advanced toward the chevron shaped seal 180 at the sealed end 176 of the pouch 174 until abutment. The sides of the folder are preferably adjacent to the first and second side seals 182, 184. The open end 178 of the pouch 74 may be sealed using a fourth seal 186 extending between the first side seal 182 and the second side seal 184. [

Referring to Figures 7C and 7D, in one embodiment, the sealed fourth end 178 of the pouch 174 is folded to rest under the bottom panel of the pouch 174. The folded end of the pouch 174 can be rounded or pinned. The folded end of the pouch may have a fold line adjacent or adjacent to the top of the folder and the back ends of the bottom panels.

8A and 8B, in one embodiment, the folded ends 178 of the pouches 174 are inserted into the carton 190 such that these folded ends abut the front end or the front end of the body of the unit- do. The IFU manual 200 can be placed on the last sealed pouch 174E loaded in the unit carton 190. [

9A, in one embodiment, when the sealed pouches 174 are inserted into the carton 190, the pouch opening flanges 185 are located at the rear or rear end of the carton. The pouch open flange is adjacent to the sheaf-shaped seal at the closed end of the pouch 174. In one embodiment, all of the pouch opening flanges 185 are rounded in the same direction.

Referring to FIG. 9B, in one embodiment, a foam insert 202 with an elongated inspection window 204 is positioned over the rounded pouch opening flanges 185 of the individually sealed pouches. The lengthy inspection window 204 allows the packing staff to verify that all of the pouch opening flanges 185 are rolled round in the same direction. The elongated inspection window 204 is also aligned with apexes of the ceiling of the ceilings of the pouches and apexes of the top edges of the ceilings of the top and bottom panels of the folder. After the foam insert 202 is placed over the pouch release flanges 185, one or more closed flaps at the back end of the carton 190 may be closed.

10A and 10B, in one embodiment, a packaging system for a sealed pouch 174 is disposed within a frame 220, such as a cardboard frame, with a top panel 222 and a bottom panel 224 . The top and bottom panels 222 and 224 at least partially encapsulate the top and bottom panels of the sealed pouch 174 to provide an additional cushioning structure for supporting the sealed pouch from the drop impact. In one embodiment, the frame 220 surrounds each sealed pouch 174 to absorb drop impacts and protects the pouch from crease formation. 10B, in one embodiment, after the sealed pouches 174 are loaded into the frame 220, the individual frames 220, which have received the sealed pouches, may have a plurality of stacked pouch / frame units It can be packed in the receiving unit carton 290.

Referring to Figure 11, in one embodiment, a pouch 174 as disclosed and described herein at least partially encapsulates the top and bottom panels of the sealed pouch 174 and defines at least the outer periphery of the sealed pouch at least And may be supported by a frame 320, such as a cardboard frame, partially enclosed. In one embodiment, each sealed pouch is disposed within one of the pouch frames 320 illustrated in FIG. The combination of the sealed pouch 174 and the pouch frame 320 may be laminated in the unit-of-sale carton disclosed herein.

Referring to Fig. 12, in one embodiment, the frames with sealed pouches may be loaded into a sales unit carton 290 'having a tear panel at the leading edge. The tear panel can be removed to gain access to the individual frames 220/320 that have received the sealed pouches 174 stacked within the sales unit carton 290 '.

Referring to Fig. 13A, in one embodiment, an additional foam insert may be used to support, cushion and protect the sealed pouch from a drop impact. In one embodiment, a series of foam inserts 202 are positioned above and below each sealed pouch 174. In one embodiment, a replenishment foam insert 205 having a central opening 207 receives the IFU manual 200, which is placed over the stack of foam inserts and sealed pouches.

Referring to Fig. 13B, in one embodiment, the carton 390 has an opening at one end. A first foam insert 202 is inserted into the carton and a first sealed pouch 174A is placed over the first foam insert 202A. In one embodiment, the folded end of the first sealed pouch 174A is first inserted into the opening at the rear end of the carton 390, followed by the shear-sealed end of the first sealed pouch 174 . The foam inserts 202 and the sealed pouches 174 are laminated together to form a stack comprising alternating foam inserts 202A and the sealed pouches 174A through 174E disposed therebetween. After both the foam inserts 202A-202E and the sealed pouches 174A-174E are inserted into the carton 390, the fill foam insert 205 with the IFU manual 200 is inserted over the stack. The flaps at the rear end of the carton 390 may then be closed to seal the sales unit carton 390.

In one embodiment, the foam inserts may be joined together as a unitary structure in which slots are formed therein to allow the sealed pouches to be inserted into the slots. In one embodiment, the foam blocks may have slots formed therein to allow pouches to be inserted into the slots.

14, in one embodiment, the foam insert 302 at the end of the carton 390 has a U-shaped opening 304 extending to the peripheral edge of the foam insert 302. The U-shaped foam insert 302 has first and second vertically extending foam columns 318A and 318B interconnected by a foam base piece 317 at the bases. In one embodiment, after the sealed pouch is inserted into the carton 390, the foam insert 302 is positioned over the pouch open flanges that are wound round the back of the carton. The U-shaped opening 304 of the foam insert 302 is preferably aligned with the leading edges of the sheath-shaped seals and the sheath-shaped shapes of the folders.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is limited only by the scope of the following claims. For example, the present invention may be embodied in any of the other embodiments described herein or illustrated in any of the other embodiments described herein, in which any of the features shown in any of the embodiments described herein, or incorporated herein by reference, May be combined with any of the features included in the specification as references, and still be considered within the scope of the present invention.

Claims (21)

A package for a medical device,
A folder having a bottom panel and an upper panel,
Wherein the bottom panel includes a leading edge, a trailing edge, and at least one medical device fixation element,
Wherein the top panel includes a leading edge and a trailing edge coupled to the trailing edge of the bottom panel to define a folding line extending between the top and bottom panels,
The folder having an unfolded configuration in which the leading edges of the top and bottom panels are directed in opposite directions, and wherein the top panel is folded over the bottom panel at the fold line so that the leading edges of the top and bottom panels The package having a folded configuration oriented in the same direction and aligned with each other. The bottom panel of claim 1, wherein the bottom panel has first and second lateral edges extending from the leading edge of the bottom panel to the trailing edge of the bottom panel, A first stress relieving slit extending inwardly from a first side edge toward a center of the bottom panel and a second stress relieving slit extending inwardly from the second side edge inwardly toward the center of the bottom panel, Wherein the first and second stress relief slits are aligned with each other along the length of the bottom panel. 3. The panel of claim 2 wherein the top panel has first and second side edges extending from the leading edge of the top panel to the trailing edge of the top panel, A first stress relief slit extending toward the center of the upper panel and a second stress relief slit extending inward from the second side edge toward the center of the upper panel, 1 and the second stress relief slits are aligned with each other along the length of the upper panel. 4. The apparatus of claim 3, wherein when the folder is in the folded configuration, the first stress relief slit of the upper panel is aligned with the first stress relief slit of the bottom panel, And the slit is aligned with the second stress relief slit of the bottom panel. 5. The package of claim 4, wherein at least one of the stress relief slits has a hole at an inner end thereof. 5. The package of claim 4, wherein at least one of the stress relief slits has an elliptical or ovoid shape, and at least one of the stress relief slits is rounded at one of the side edges. The medical device of claim 1, wherein the package further comprises a three-dimensional medical device secured on the bottom panel of the folder, the top panel covering the three-dimensional medical device when the folder is in the folded configuration, package. 8. The apparatus of claim 7, wherein the bottom panel comprises at least one medical device securing element for securing the three-dimensional medical device to the bottom panel, wherein the at least one medical device securing element is secured to the at least one medical device fixture Wherein the element is coupled to the bottom panel through a fold line that allows the element to fold flat over the bottom panel or extend away from the bottom panel to engage the three-dimensional medical device. 8. The pouch of claim 7, wherein the package further comprises a pouch, the pouch having a first leg extending adjacent the leading end and a second leg extending toward the first and second sides of the pouch, wherein the first leg of the seal comprises a first sheet of material and a second sheet of material joined together by a seal having second and third legs extending adjacent the first and second legs, The bottom panels having a shape that matches the shape of the leading edges of the bottom panels. 10. The method of claim 9, wherein the first legs of the seal and the leading edges of the top and bottom panels have chevron shapes conforming to one another, Edges of the upper and lower panels are adjacent to the first leg of the shehenhorn shape of the seal of the pouch and the first side edges of the upper and lower panels are adjacent the second leg of the seal, Wherein the second side edges are disposed within the pouch with the third legs adjacent the third leg of the seal. 11. The apparatus of claim 10, wherein the seal is located between the second and third legs of the seal and the trailing end of the pouch to seal the folder and the three-dimensional medical device in the pouch Further comprising an extended fourth leg. 12. The apparatus of claim 11 wherein the rear end of the sealed pouch comprising the fourth leg of the seal is folded under the folder to define a pouch fold, Adjacent to the edges. 13. The method of claim 12,
A carton having a leading end and a trailing end;
Further comprising a plurality of the sealed pouches disposed within the carton,
Each said sealed pouch comprising a first leg of said sheath of said seal located adjacent said pouch fold and said rear end of said carton adjacent said distal end of said carton. The package of claim 1, wherein the folder comprises a material selected from the group of materials consisting of a durable material, a smooth material, a paperboard, a cardboard, and a high density polyethylene (HDPE). 10. The package of claim 9, wherein the pouch comprises a material selected from the group consisting of a foil polyester laminate, a foil nylon laminate, and a heat sealable laminate. A package for a medical device,
CLAIMS What is claimed is: 1. A sealed pouch comprising: a first leg extending adjacent a distal end of the pouch; second and third legs extending adjacent the first and second sides of the pouch; The sealed pouch comprising two sheets of material joined together by a seal having an extended fourth leg;
CLAIMS What is claimed is: 1. A folder for receiving a medical device, the folder comprising a bottom panel and an upper panel,
Lt; / RTI >
Wherein the bottom panel includes a leading edge and a trailing edge,
Wherein the top panel includes a leading edge and a trailing edge coupled to the trailing edge of the bottom panel to define a fold line extending between the top and bottom panels,
Wherein the top panel is folded over the bottom panel at the fold line so that the leading edges of the top and bottom panels are oriented in the same direction and aligned with each other,
Wherein the folder is disposed within the sealed pouch with the leading edges of the top and bottom panels of the folder adjacent the first leg of the seal of the sealed pouch. 17. The seal of claim 16 wherein the first leg of the seal has a chevron shape and the leading edges of the top and bottom panels have chevron shapes conforming to the chevron shape of the first leg of the seal , package. 18. The apparatus of claim 17, wherein the bottom panel includes first and second side edges extending from the chevron-shaped leading edge of the bottom panel to the trailing edge of the bottom panel, A first stress relief slit extending toward the center of the bottom panel and a second stress relief slit extending inwardly from the second side edge toward the center of the bottom panel, The slits are aligned with one another along the length of the bottom panel and the outer ends of the first and second stress relief slits are rounded at the first and second side edges of the respective ones of the bottom panels. 19. The method of claim 18, wherein the top panel includes first and second side edges extending from the chevron-shaped leading edge of the top panel to the trailing edge of the top panel, A first stress relief slit extending toward the center of the upper panel and a second stress relief slit extending inwardly from the second side edge toward the center of the upper panel, Wherein the second stress relief slits are aligned with each other along the length of the upper panel and the outer ends of the first and second stress relief slits of the upper panel are spaced from each other at the first and second side edges of the upper panel Rounded, package. 20. The apparatus of claim 19, wherein when the top panel is folded over the bottom panel, the first stress relief slit of the top panel is aligned with the first stress relief slit of the bottom panel, And the stress relief slit is aligned with the second stress relief slit of the bottom panel. 21. The apparatus of claim 20, wherein the package further comprises a three dimensional medical device secured to the bottom panel of the folder, the bottom panel of the folder securing the three dimensional medical device to the bottom panel of the folder Wherein the three-dimensional medical device comprises a section forming the thickest portion of the three-dimensional medical device, and wherein the stress relief slits on the top and bottom panels comprise at least one of the three- And is aligned with the thickest portion of the medical device.

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